Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT01315002
Eligibility Criteria:
Inclusion Criteria:
Patients:
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of schizophrenia
* age 18-55 years old
* able to provide informed consent
* treated with antipsychotic medications at a stable dose for at least 6 weeks
* normal or corrected to normal vision
* smokers (Fagerström Test for Nicotine Dependence \> 4)
* non-smokers (\< 100 cigarettes/lifetime, not having smoked in the past year)
Controls:
* age 18-55 years old
* able to provide informed consent
* normal or corrected to normal vision
* smokers (Fagerström Test for Nicotine Dependence \> 4)
* non-smokers (\< 100 cigarettes/lifetime, not having smoked in the past year)
Unaffected First-Degree Relatives of Schizophrenia Patients:
* same inclusion criteria as controls plus
* having an adult first-degree relative (sibling, parent, child) with a DSM IV diagnosis of schizophrenia
Exclusion Criteria:
Patients:
* substance dependence
* clinical instability
* changes in medication in the last 6 weeks
* anticholinergic medication
* untreated hypertension
* cardiovascular disease
* insulin-dependent diabetes mellitus
* phaeochromocytoma
* uncontrolled hyperthyroidism
* renal or hepatic impairment
* central nervous system disease
* pulmonary disease
* generalised dermatological disorders (neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)
* gastric or intestinal ulcer
* hypersensitivity to nicotine
* allergy to patches
* women: pregnancy, lactation
Controls:
* substance dependence
* having a first-, second-, or third-degree relative with a psychotic disorder
* DSM IV Axis I disorder
* anticholinergic medication
* untreated hypertension
* cardiovascular disease
* insulin-dependent diabetes mellitus
* phaeochromocytoma
* uncontrolled hyperthyroidism
* renal or hepatic impairment
* central nervous system disease
* pulmonary disease
* generalised dermatological disorders (neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)
* gastric or intestinal ulcer
* hypersensitivity to nicotine
* allergy to patches
* women: pregnancy, lactation
Unaffected First-Degree Relatives of Schizophrenia Patients:
* same exclusion criteria as controls
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01315002
Study Brief:
Protocol Section:
NCT01315002